The following data is part of a premarket notification filed by Corpak Medsystems with the FDA for Neo Mapcath Sensor Stylet.
| Device ID | K083121 |
| 510k Number | K083121 |
| Device Name: | NEO MAPCATH SENSOR STYLET |
| Classification | Percutaneous, Implanted, Long-term Intravascular Catheter Accessory For Catheter Position |
| Applicant | CORPAK MEDSYSTEMS 100 CHADDICK DR. Wheeling, IL 60090 |
| Contact | Stephanie Wasielewski |
| Correspondent | Stephanie Wasielewski CORPAK MEDSYSTEMS 100 CHADDICK DR. Wheeling, IL 60090 |
| Product Code | OMF |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-22 |
| Decision Date | 2009-02-11 |